Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Cisatracurium Versus Atracurium on Intraocular Pressure in Patients Underwent General Anesthesia

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01273831
First received: January 10, 2011
Last updated: NA
Last verified: July 2009
History: No changes posted

January 10, 2011
January 10, 2011
July 2009
December 2009   (final data collection date for primary outcome measure)
intraocular pressure [ Time Frame: at 2 minutes after intubation ] [ Designated as safety issue: Yes ]
determining intraocular pressure in atracurium and cisatracurium groups
Same as current
No Changes Posted
systolic blood pressure [ Time Frame: at 2 minutes after intubation ] [ Designated as safety issue: Yes ]
identification of systolic blood pressure in atracurium and cisatracurium groups
Same as current
Not Provided
Not Provided
 
Effect of Cisatracurium Versus Atracurium on Intraocular Pressure in Patients Underwent General Anesthesia
Study of Effects of Cisatracurium and Atracurium on Intraocular Pressure

The purpose of this study is to determine which drug makes lower intraocular pressure

Increase in intraocular pressure (IOP) following tracheal intubation during general anesthesia can be troublesome. The investigators compared the influence of cisatracurium and atracurium on IOP in patients undergoing general anesthesia.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Intraocular Pressure
  • Drug: atracurium
    atracurium, Drop,0.5 mg/kg, one time, one day
  • Drug: cisatracurium
    cisatracurium, drop,0.15mg/kg,one time, one day
  • atracurium
    Patients who underwent general anesthesia received atracurium
    Intervention: Drug: atracurium
  • cisatracurium
    Patients who underwent general anesthesia received cisatracurium
    Intervention: Drug: cisatracurium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

ASA class of I or II baseline IOP of lower than 20 mmHg stable hemodynamics no history of ophthalmic diseases not using drugs affecting IOP (e.g. anticholinergics, sympathomimetics) no contraindication for atracurium or cisatracurium administration.

Exclusion Criteria:

difficulty in mask ventilation or in tracheal intubation end expiratory CO2 of below 35 mmHg or over 45 mmHg O2 saturation of below 90%

Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01273831
ASD-1213-10
Yes
Dr. Alireza Yousefy/Associate Professor of Medical Education, Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
Not Provided
Study Chair: Mitra Jabalameri, A.Professor Associate Professor,Anesthesiology department
Isfahan University of Medical Sciences
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP